BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS— 510(k) K101122

Substantially Equivalent

Benz Research and Development Corp.

FDA 510(k) clearance K101122 for BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS, Substantially Equivalent on 2010-08-09. Applicant: Benz Research and Development Corp.. Device class: 2.

Clearance details

Applicant
Benz Research and Development Corp.
Product code
Code LPL
Device class
Class 2
Regulation
21 CFR 886.5925
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sarasota, FL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LPL

product code LPL
Injury
988
Other
4
Total
992

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.